Clinical Trial Search

Primary: 11C-PBR28 Uptake as Measured by Standardized Uptake Values Normalized by a Pseudoreference Region (SUVR) — 0.9; 0.9; 1.31; 0.84 SUVR — p=0.011

Primary: Part A: Number of Participants With Adverse Events (AEs) — 8; 4; 1; 3 participants

Primary: Number of Patients With a Return of Disease Activity After the Third Month Post-first-infusion — 3; 6 Participants

Primary: Expanded Disability Status Scale (EDSS) Improvement — 3.4; 3.3; 2.5; 3.7 units on a scale

Primary: Adjusted Annualized Relapse Rate (ARR) — 0.393; 0.216 relapses per person-years — p=< 0.0001

Primary: Number of Participants With Adverse Events as a Measure of Safety and Tolerability — 100; 12; 0 Participants

Primary: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs, Withdrawals Due to AEs — 358; 148; 91; 90 Participants

Primary: Number of Participants With Anti-DAC HYP Binding Antibodies (ADAbs): Electrochemiluminescent (ECL) Anti-Drug Antibody (ADA) Assay — 78; 35; 92; 21 participants

Primary: Measure: Number of Subjects With Adverse Events, Number of Abnormalities in Safety Assessments — 12; 8 participants

Primary: Total Number of Gadolinium-Enhancing T1 Lesions Observed on Magnetic Resonance Imaging (MRI) Scans of the Brain — 5.6; 0.6; 0.2; 6.9 lesions — p=<0.0001

Primary: Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) — 519; 212; 207; 69 Participants

Primary: Estimated Annualized Aggregate Relapse Rate (ARR) — 0.16; 0.18; 0.40 Relapses per year

Primary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) — 2; 1; 3; 9 Participants

Primary: Score on the Berg Balance Scale — 54.43; 51.43; 54.67; 50.33 units on a scale

Primary: Total Number of Confirmed Relapses During the Placebo Controlled (PC) Treatment Period Estimated by Negative Binomial Regression — 0.331; 0.505 confirmed relapses…